Let’s face it — vaccine documentation isn’t flashy, but it’s absolutely foundational. Unfortunately, knowledge gaps on this topic are surprisingly common. Immunize.org offers an “Ask the Experts: Documenting Vaccination” webpage, which includes 26 questions and answers. Addressing a variety of related topics, it’s a must-read (or at least a must-skim) for all vaccination providers.
In the April issue of Technically Speaking, we review four common questions posed by providers on vaccination documentation.
QUESTION 1. What information does federal law require us to document when we immunize a patient?
Under the National Childhood Vaccine Injury Act (NCVIA), certain documentation is required for all routinely recommended childhood and pregnancy vaccines (excluding COVID-19 and RSV), regardless of the patient’s age.
The following information is required to be recorded in the patient’s medical record or permanent office log:
- Vaccine manufacturer.
- Lot number of the vaccine.
- Date of administration.
- Name, office address, and title of the healthcare provider administering the vaccine.
- Vaccine Information Statement (VIS) edition date (back, lower right corner); for combination vaccines, all applicable VISs should be recorded.
- Date the VIS is given to the patient, parent or guardian.
These records must be permanent and accessible.
QUESTION 2. I know that providers are required to give the patient (or parent/legal representative of a minor) a copy of the relevant VIS before administering any vaccine covered by the National Childhood Vaccine Injury Act (NCVIA). Nirsevimab (Beyfortus, Sanofi) is not a vaccine, so do we have to give a VIS before administering it?
As you imply, nirsevimab is a monoclonal antibody rather than a vaccine. However, a VIS-equivalent, known as an immunization information sheet (IIS), is available and should be provided to the caregiver of an infant receiving nirsevimab. For the English version of this sheet and 24 translations of it see Immunize.org’s webpage “Immunization Information Statement (IIS) – Respiratory Syncytial Virus (RSV) Preventive Antibody.”
QUESTION 3. For cost savings, we provide an electronic copy of the VIS. Does this comply with federal law? Also, do we need to have parents sign a document stating that they received the VIS?
Providing an electronic version, such as QR code access in the room or in their after-visit summary, complies with federal law. Immunize.org offers three documents with QR codes that, when clicked, lead to a VIS:
- QR Code Links to All Vaccine Information Statements (VISs)
- QR Code Links to Routinely Recommended Vaccine Information Statements (VISs)
- QR Code Links to Vaccine Information Statement (VIS) Translations: Influenza (Flu) Vaccine (Inactivated or Recombinant)
While there is no federal requirement for signed consent, some states or agencies may require it.
QUESTION 4. I had a patient with an allergic reaction to a dose of DTaP vaccine. What documentation is required?
According to the VIS, adverse reactions, including allergic reactions, should be reported to the Vaccine Adverse Event Reporting System (VAERS). The healthcare provider will usually be the person to file this report. However, the family can do it themselves by visiting the VAERS website or calling 1-800-822-7967. VAERS is only for reporting reactions, not for obtaining medical advice.
Additionally, ensure that you follow the process outlined by your practice for documenting allergic reactions in the patient’s health record. Individuals with severe allergic reactions are rare, so symptoms should be carefully reviewed to understand if the patient had a true allergic reaction, which would limit receipt of diphtheria-, tetanus-, and pertussis-containing vaccines in the future.
Wrap Up
Share this information, and the rest of the Immunize.org "Ask the Experts: Documenting Vaccination" webpage, with those responsible for vaccine documentation compliance in your practice. These may seem like fussy details, but they are an important part of providing the highest quality vaccination delivery.
Contributed by: Sharon G. Humiston, MD, MPH, FAAP
Let’s face it — vaccine documentation isn’t flashy, but it’s absolutely foundational. Unfortunately, knowledge gaps on this topic are surprisingly common. Immunize.org offers an “Ask the Experts: Documenting Vaccination” webpage, which includes 26 questions and answers. Addressing a variety of related topics, it’s a must-read (or at least a must-skim) for all vaccination providers.
In the April issue of Technically Speaking, we review four common questions posed by providers on vaccination documentation.
QUESTION 1. What information does federal law require us to document when we immunize a patient?
Under the National Childhood Vaccine Injury Act (NCVIA), certain documentation is required for all routinely recommended childhood and pregnancy vaccines (excluding COVID-19 and RSV), regardless of the patient’s age.
The following information is required to be recorded in the patient’s medical record or permanent office log:
- Vaccine manufacturer.
- Lot number of the vaccine.
- Date of administration.
- Name, office address, and title of the healthcare provider administering the vaccine.
- Vaccine Information Statement (VIS) edition date (back, lower right corner); for combination vaccines, all applicable VISs should be recorded.
- Date the VIS is given to the patient, parent or guardian.
These records must be permanent and accessible.
QUESTION 2. I know that providers are required to give the patient (or parent/legal representative of a minor) a copy of the relevant VIS before administering any vaccine covered by the National Childhood Vaccine Injury Act (NCVIA). Nirsevimab (Beyfortus, Sanofi) is not a vaccine, so do we have to give a VIS before administering it?
As you imply, nirsevimab is a monoclonal antibody rather than a vaccine. However, a VIS-equivalent, known as an immunization information sheet (IIS), is available and should be provided to the caregiver of an infant receiving nirsevimab. For the English version of this sheet and 24 translations of it see Immunize.org’s webpage “Immunization Information Statement (IIS) – Respiratory Syncytial Virus (RSV) Preventive Antibody.”
QUESTION 3. For cost savings, we provide an electronic copy of the VIS. Does this comply with federal law? Also, do we need to have parents sign a document stating that they received the VIS?
Providing an electronic version, such as QR code access in the room or in their after-visit summary, complies with federal law. Immunize.org offers three documents with QR codes that, when clicked, lead to a VIS:
- QR Code Links to All Vaccine Information Statements (VISs)
- QR Code Links to Routinely Recommended Vaccine Information Statements (VISs)
- QR Code Links to Vaccine Information Statement (VIS) Translations: Influenza (Flu) Vaccine (Inactivated or Recombinant)
While there is no federal requirement for signed consent, some states or agencies may require it.
QUESTION 4. I had a patient with an allergic reaction to a dose of DTaP vaccine. What documentation is required?
According to the VIS, adverse reactions, including allergic reactions, should be reported to the Vaccine Adverse Event Reporting System (VAERS). The healthcare provider will usually be the person to file this report. However, the family can do it themselves by visiting the VAERS website or calling 1-800-822-7967. VAERS is only for reporting reactions, not for obtaining medical advice.
Additionally, ensure that you follow the process outlined by your practice for documenting allergic reactions in the patient’s health record. Individuals with severe allergic reactions are rare, so symptoms should be carefully reviewed to understand if the patient had a true allergic reaction, which would limit receipt of diphtheria-, tetanus-, and pertussis-containing vaccines in the future.
Wrap Up
Share this information, and the rest of the Immunize.org "Ask the Experts: Documenting Vaccination" webpage, with those responsible for vaccine documentation compliance in your practice. These may seem like fussy details, but they are an important part of providing the highest quality vaccination delivery.
Contributed by: Sharon G. Humiston, MD, MPH, FAAP